Breathing assistance apparatus

ABSTRACT

The present invention may include an integral, separable or separate humidifier ( 100 ) which may be selectively configured to an inoperative or operative state. The switch over is dependent on the user or the seller having access to an actuation tool to activate the humidifier. The Continuous Positive Airway Pressure (CPAP) device is initially available for use as a standalone CPAP ( 100 ). The heater plate being isolated by a covering shroud ( 102 ), the shroud ( 102 ) also forms a connection port for the CPAP blower outlet ( 104 ). The heated humidification hardware being disabled by the absence of the activation tool. Upgrade to a CPAP device including heated humidification is completed by the installation of the actuation tool. Removal of the heater plate isolating shroud and/or installing the actuation tool enables the software controlled heated humidification hardware for heated humidifier operation. Other upgrades to functionality are also disclosed.

FIELD OF INVENTION

The present invention relates to humidification particularly though notsolely to humidifying gases to a user requiring Continuous PositiveAirway Pressure (CPAP).

SUMMARY OF THE PRIOR ART

It is known in the art to provide CPAP treatment in conjunction withhumidity, see for example U.S. Pat. No. 6,050,260. The humidification isusually provided either by:

-   -   1. An integrated CPAP blower and humidifier as described in U.S.        Pat. No. 6,050,260, whereby there is no separation of the CPAP        and heated humidifier except for the humidification chamber for        filling and cleaning.    -   2. A standalone CPAP device connected by a flexible airway tube        to a standalone heated humidifier, the equipment generally        mounted on a tray for stability.    -   3. A CPAP device that can standalone but can also be attached to        a modular heated humidifier. No flexible airway tube nor        mounting tray is required.

It would be desirable to provide a CPAP device which could be easilyupgraded to provide humidification.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a breathingassistance apparatus which goes someway to achieving the abovementioneddesiderata, overcoming the abovementioned disadvantages or at leastprovides the public with a useful choice.

Accordingly in a first aspect the invention consists in a breathingassistance apparatus comprising:

a gas delivery device adapted to provide gas at a substantially positivemean pressure;

a humidifier adapted to humidify said gas and;

wherein said apparatus is configurable to at least two configurations, afirst configuration with a predetermined functionality inoperable withsaid gas delivery device operable and a second configuration with saidpredetermined functionality and said device operable.

In a second aspect the invention consists in a breathing assistanceapparatus comprising:

means for providing gas at a substantially positive mean pressure;

means for humidifying said gas; and

means for providing at least two configurations, a first configurationwith a predetermined functionality inoperable and a second configurationwith said predetermined functionality.

In a third aspect the invention consists in a method of deliveringrespiratory gases to a patient comprising the steps of:

providing gas at a substantially positive mean pressure;

humidifying said gas; and

providing at least two configurations, a first configuration with apredetermined functionality inoperable and a second configuration withsaid predetermined functionality.

Wherein said predetermined functionality is active humidification andsaid second configuration occurs by the engagement of a predeterminedmechanical key with said apparatus.

Wherein said predetermined functionality is active humidification andsaid second configuration occurs by the engagement of a predeterminedmechanical key with said apparatus said second configuration occurs bythe engagement of a predetermined magnetic key with said apparatus.

Wherein said predetermined functionality is active humidification andsaid second configuration occurs by the engagement of a predeterminedmechanical key with said apparatus said second configuration occurs bythe entry of a predetermined code into a keypad.

Wherein said predetermined functionality is active humidification andsaid second configuration occurs by the engagement of a predeterminedmechanical key with said apparatus a portion of said apparatus may beseparated corresponding to said first configuration, whereby theintegration of said portion corresponds to said second configuration.

Wherein said predetermined functionality is active humidification andsaid second configuration occurs by the engagement of a predeterminedmechanical key with said apparatus said second configuration occurs byintroducing a software or hardware dongle.

Wherein said apparatus further comprises a conduit between the deviceand the patient and said predetermined functionality is activehumidification and heater within or incorporated with said conduit.

Wherein said predetermined functionality relates to heating said gas andsaid second configuration relates to energising said heater to heat saidconduit and/or said gas directly.

Wherein said predetermined functionality relates to storage or displayof data relating to the use of said apparatus and said secondconfiguration relates to energising a display to indicate said use.

Wherein said predetermined functionality relates to the pressure level,delivered to the patient and said second configuration relates toproviding either a continuous or stepwise correction in sound pressurelevel.

In a fourth aspect the invention consists in a apparatus for deliveringgas to a patient comprising a gas delivery device configured to providegas at a predetermined pressure level,

a heater,

a chamber having an inlet and an outlet,

said inlet configured to receive gas from said device,

including a body of water whereby said body of water being heated bysaid heater providing vapour within said chamber thereby humidifyinggases passing from said inlet to said outlet,

a controller or processor configured to energise said heater accordingto at least a user selectable level,

a cover configured to prevent user selection of said heating level andproviding an outlet directly from said device,

wherein when said chamber is installed in proximity to said heater saidapparatus delivers humidified gas to a patient at a predeterminedpressure level,

and when said chamber is removed and said cover is installed saidapparatus delivers unhumidified gas to a patient at a predeterminedpressure level.

Wherein said cover may be removed using a mechanical key to disengage itwith said apparatus.

Wherein said apparatus further comprises a control input configured toprovide user selection to said controller.

Wherein said input may be locked to prevent user input and unlocked byengaging a mechanical key with said input.

In a fifth aspect the invention consists in a apparatus for deliveringgas to a patient comprising a gas delivery device configured to providegas at a predetermined pressure level,

a heater,

a chamber having an inlet and an outlet,

said inlet configured to receive gas from said device,

including a body of water whereby said body of water being heated bysaid heater providing vapour within said chamber thereby humidifyinggases passing from said inlet to said outlet,

a controller or processor configured to energise said heater accordingto at least a user selectable level.

a user input configured to selectively enable or disable said heaterand/or other functionality associated with said apparatus.

Wherein said apparatus further comprises a display adapted to indicatethe current level of functionality enabled.

This invention may also be said broadly to consist in the parts,elements and features referred to or indicated in the specification ofthe application, individually or collectively, and any or allcombinations of any two or more of said parts, elements or features, andwhere specific integers are mentioned herein which have knownequivalents in the art to which this invention relates, such knownequivalents are deemed to be incorporated herein as if individually setforth.

The invention consists in the foregoing and also envisages constructionsof which the following gives examples.

BRIEF DESCRIPTION OF THE DRAWINGS

One preferred form of the present invention will now be described withreference to the accompanying drawings in which

FIG. 1 is a perspective view of the CPAP only configuration;

FIG. 2A is a blown out view of the CPAP only configuration;

FIG. 2B is a reverse angle of FIG. 2A;

FIG. 3 is a perspective view of the humidified CPAP configuration;

FIG. 4 is a front view showing another example control panel; and

FIG. 5 is a front view showing an alternative control panel.

DETAILED DESCRIPTION

A typical integrated CPAP humidifier is described in U.S. Pat. No.6,050,260. The contents of which are incorporated herein by reference.

The present invention may include an integral, separable or separatehumidifier which may be selectively configured to an inoperative oroperative state. The switch over is dependent on the user or the sellerhaving access to an actuation tool (described later) to activate thehumidifier.

Referring to FIG. 1 a CPAP device 100 is initially available for use asa standalone CPAP. In this configuration, the heater plate 106 isisolated by a covering shroud 102. The shroud 102 also forms aconnection port 104 for the CPAP blower outlet. The heatedhumidification hardware is disabled by the absence of the activationtool.

Upgrade to a CPAP device that includes heated humidification iscompleted by the installation of the actuation tool. Removal of theheater plate isolating shroud 102 shown in FIG. 3, and/or installing theactuation tool enables the software controlled heated humidificationhardware for heated humidifier operation.

Examples of the various forms of actuation tool could include:

1. Software Key via Serial Data Port

The CPAP device could be connected via RS232 serial connection to acomputer or directly via TCP/IP or telephone line to the Internet toreceive either additional software or coded actuation data.

2. Mechanical Key

The heater plate vestibule is covered by a shroud 102. A mechanical key(110, FIG. 2A) is used to remove the shroud 102. The heater platecontrol knob 108 is locked off by the shroud 102 as shown in FIG. 2A.The upgrade kit may include a knob to turn the heater plate 106 on. Inone embodiment shown in FIGS. 2A & 2B engaging the key 110 pushes twosnap fit flanges 112, allowing the shroud 102 to be removed.

3. Magnetic Key

Also includes a shroud 102 as in FIG. 2 but in addition there is a keywhich has magnets in a predetermined pattern. This key is slid into acavity in the case. Inside the case there are Hall effect sensors thatdefect the pattern of magnets. If the key is detected, the heater plateis activated.

4. Code Number Verification

Also includes a shroud 102 as in FIG. 2 but in addition there is a codenumber that is entered into the device. The dealer phones a freephonenumber with the serial number of the CPAP device and pays for theupgrade. The freephone service then gives the dealer a code number thatis specific to the serial number of the CPAP device. This code number isthen entered into a keypad (not shown) to activate the humidifier.

The freephone service could also be an Internet based service.

Another alternative is that the upgrade kit includes a card with anumber hidden inside the packaging. This number then gives the freephoneservice evidence that the dealer has paid for the kit, and the financialtransaction then doesn't have to be conducted on the phone. Similarly toprevent fraud the numbers could be stored such that if a number is usedtwice an alarm is raised.

5. Dongle

A plug in pack containing an electronic circuit designed to respond in apredetermined way to interrogation by the CPAP device. The plug in packcould plug into a dedicated socket in the device or into the existingserial port. Similarly a smart card of known type could be interfacedwith the CPAP device to activate the humidifier.

Additionally, the dongle may contain some of the electronic circuitneeded to operate the heater plate. Again a shroud 102 as seen in FIGS.1 and 2 would be required.

6. Removable Heater Plate

The CPAP device is supplied with a plastic cradle where the heater platecurrently is. The plastic cradle has all of the mounting and springingarrangement that the current heater plate has. the cradle also has anelectrical connector and clips. A second part consisting of the pressedmetal heater plate top surface with the element, thermistor and thermalcutout bonded to it is then supplied in the upgrade kit. The dealer canthen remove the shroud and plug the heater plate into the cradle. Theplastic cradle means that the fixings and spring mechanism can bepreassembled inside the unit so that the heater plate can be installedwithout tools and without the need to disassemble the unit.

It will be appreciated that while in the preferred embodiment theunhumidified CPAP configuration utilises a shroud 102 over the heaterplate, this is not required. The heater plate 106, could be rendered ininoperable/operable by any of the methods described, but with the waterchamber 200 in place in both configuration.

7. Cold Passover

Whereas the system in FIG. 3 includes at least the water chamber thiscould operate in both humidified and non humidified modes. For examplethe heater plate need not be initially supplied. The heater plate may besupplied but not activated.

Activating the heater plate could occur for example:

-   -   1. Heater plate control is by a rotary potentiometer 108, 400.        This can be incapacitated by a lock to physically prevent the        potentiometer from turning. Upgrade to active humidification        requires a second key to remove the potentiometer lock and        activate the heater.    -   2. Heater control is by a setting in a menu accessed by buttons.        Upgrade to active humidification requires a PIN number to        activate the heater plate. Referring to FIG. 5 the key pad 500        is shown.        8. Heated Tube

The system could include a heated tube to deliver the gas to avoidcondensation. Again this might be incapacitated initially.

Activating the heated tube control could occur by example:

-   -   1. Heater tube control by a rotary potentiometer 402, which is        locked to physically prevent the potentiometer from turning.        Upgrade requires a third key to remove the heated tube        potentiometer lock and activate the heated tube.    -   2. Heated tube control by a setting in a menu accessed by        buttons. Upgrade requires a PIN number to activate the heated        tube.

Example upgrade kits could be:

Cold passover kit: Contains a chamber, key #1 to remove cover.

Heated humidification kit: Contains chamber, key #1 to remove cover andkey #2 to remove the potentiometer lock OR a PIN number to activate theheater.

Heated tube kit: Contains chamber, key #1 to remove cover, key #2 toremove the potentiometer lock OR a PIN number to activate the heater.Key #3 to remove the heated tube potentiometer lock OR a second PINnumber.

9. Other Functionality Upgrade

The electronic or mechanical key could also be used to upgrade otherfunctionality. For example the applicant has identified it might bedesirable to store and/or display data in relation to patientcompliance, or use of the treatment.

Referring to FIG. 5 we see a screen 502 for display of such compliancedata. Depending on the key used example levels of functionality aregiven below:

Option 1: Machine displays no information.

Option 2: Machine displays machine run time only.

Option 3: Machine displays summary data on the display. For example,average hours complied per night used.

Option 4: Full compliance data download. All the day to data stored inthe machine can be downloaded to a PC for analysis. Summary data wouldalso be displayed.

It would be possible to activate any of these options by entering asuitable PIN number, or any other method, previously described or not.

This method could also apply to upgrading any function of the machinefor example different levels of delivered pressure for inhalation versusexhalation and automatically calibrating the pressure level depending onsymptoms exhibited by the patient.

1. An integrated breathing assistance apparatus for use as part of asystem for providing respiratory gases to a user, comprising: a gasesdelivery device adapted to provide respiratory gases at a substantiallypositive mean pressure through an outlet, a heater plate, adapted toreceive a water chamber and heat the contents of said chamber in use,said gases delivery device and said heater plate rigidly connectedtogether, a controller adapted to energise said integrated breathingassistance apparatus to at least two configurations, a firstconfiguration where said gases delivery device is operable to providerespiratory gases at a substantially positive mean pressure through saidoutlet and said heater plate is non-operable, and a second configurationwhere said gases delivery device is operable to provide respiratorygases at a substantially positive mean pressure through said outlet, andsaid heater plate is also operable, said controller configuring saidapparatus into said second configuration when an activation tool isengaged with the apparatus, said controller configuring said apparatusto said first configuration when said activation tool is absent.
 2. Anapparatus as claimed in claim 1 wherein said apparatus includes saidactivation tool and said apparatus further includes a communicationport, said activation tool being a software key, in use a usercommunicating said software key to said controller via saidcommunication port so that said controller configures said apparatusinto said second configuration.
 3. An apparatus as claimed in claim 1wherein said apparatus further includes a shroud, said shroud adapted tocover said heater plate and lock to said apparatus, a user unlockingsaid shroud using a mechanical key and removing said shroud from saidapparatus when a user wishes to use said apparatus in said secondconfiguration.
 4. An apparatus as claimed in claim 3 wherein saidapparatus inches hall affect sensors in communication with saidcontroller, and said activation tool is a magnetic key having magnetsarranged in a predetermined pattern, said hall effect sensors arrangedso as to detect said magnets when said key is engaged with saidapparatus, in use a user engaging said activation tool with saidapparatus so that said controller configures said apparatus into saidsecond configuration.
 5. An apparatus as claimed in claim 3 wherein saidapparatus includes a communication port, and said activation tool is adongle containing an electronic circuit, said electronic circuit andsaid controller mutually adapted to communicate with one another whensaid dongle is engaged with said apparatus via said communication port,said electronic circuit providing a predetermined response tointerrogation by said controller, in use a user engaging said donglewith said communication port so that said controller configures saidapparatus into said second configuration upon receipt of saidpredetermined response.
 6. An apparatus as claimed in claim 3 whereinsaid heater plate is repeatedly removable and replaceable from saidapparatus, said heater plate being adapted to integrate with saidapparatus once said shroud is removed, integration of said removableheater plate with said apparatus enabling said controller so that saidcontroller configures said apparatus into said second configuration. 7.An apparatus as claimed in claim 3 wherein said apparatus includes auser-operable key pad in communication with said controller, saidactivation tool being a PIN, said controller configuring said apparatusinto said second configuration when a use enters a PIN via said key pad.8. An apparatus as claimed in any one of claims 3 to 7 wherein saidapparatus is adapted to connect to a conduit, said conduit providingsaid gases to a user, said conduit having a conduit heater, said conduitheater being inoperable in said first and second configurations, saidapparatus being configurable to a third configuration wherein said gasesdelivery device is operable and said heater plate is operable and saidconduit heater is operable, said controller configuring said apparatusto said third configuration when one of said activation tool and asecond activation tool is engaged with the apparatus.
 9. An apparatus asclaimed in claim 8 wherein said apparatus further includes auser-operable key pad in communication with said controller, said secondactivation tool being a conduit heater PIN, said controller configuringsaid apparatus into said third configuration when a user enters saidconduit heater PIN via said key pad.
 10. An integrated breathingassistance apparatus for use as part of a system for providingrespiratory gases to a user, comprising: a gases delivery device forproviding gases at a predetermined pressure level, a heater plateadapted to receive a water chamber and heat the contents of said chamberin use, said gases delivery device and said heater plate rigidlyconnected together, a controller configured to energise said heateraccording to at least a user selectable level, a removable coverconfigured to prevent user selection of said user selectable level andprovide an outlet from said gas delivery device, wherein when said coveris installed, said apparatus is adapted to deliver un-humidified gasesvia said outlet at a predetermined pressure level, and when said coveris removed and at least a humidification chamber containing water isinstalled in proximity to said heater, said chamber having a chamberinlet and a chamber outlet, said chamber inlet being configured toreceive gases from said gas delivery device, said apparatus is adaptedto deliver humidified gases via the chamber outlet.
 11. An apparatus asclaimed in claim 10 wherein said cover is adapted to lock to saidapparatus, a user unlocking the cover using a mechanical key to removethe cover from said apparatus.
 12. An apparatus as claimed in claim 11further comprising a control input configured to provide user selectionof said user selectable level to said controller.
 13. An apparatus asclaimed in claim 12 wherein said control input may be locked to preventuser selection of said user selectable level and unlocked to allow userselection of said user selectable level, said control input beingunlocked by engaging a control input mechanical key with said apparatus.14. An apparatus as claimed in claim 10 wherein said heater plate isrepeatedly removable and replaceable from said apparatus, said heaterplate being adapted to integrate with said apparatus once said cover isremoved.
 15. An apparatus as claimed in any one of claims 10 to 14wherein the chamber outlet is adapted to be connected to a conduit, theconduit providing said gases to a user, the conduit having a conduitheater for heating the gases in the conduit, the controller beingconfigured to energise said conduit heater according to at least a userselectable conduit heating level, the apparatus having a conduit heatercontrol input configured to provide user selection of said conduitheating level.
 16. An apparatus as claimed in claim 15 wherein saidconduit heater control input may be locked to prevent user selection ofsaid conduit heating level and unlocked to allow user selection of saidconduit heating level, said conduit heater control input being unlockedby engaging a conduit heater control input mechanical key with saidapparatus.
 17. A method of controlling an apparatus for deliveringrespiratory gases to a patient comprising the steps of: energising agases delivery device to provide gases at a positive mean pressure;configuring the apparatus to energise a humidifier based on the presenceof an activation tool, said humidifier being adapted to or adaptable tohumidify said gases to a humidification level, providing the respiratorygases un-humidified at a positive mean pressure with the absence of theactivation tool, and providing the respiratory gases at a positive meanpressure humidified to the humidification level with the engagement ofthe activation tool with the apparatus.